Public Assessment Report. Scientific discussion. Calcium and Vitamine D3 Alpex 1000 mg/880 IE, effervescent granules

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1 Public Assessment Report Scientific discussion Calcium and Vitamine D3 Alpex 1000 mg/880 IE, effervescent granules (calcium carbonate and cholecalciferol) NL License RVG: Date: 12 March 2015 This module reflects the scientific discussion for the approval of Calcium en Vitamine D3 Alpex 1000 mg/880 IE, effervescent granules. The marketing authorisation was granted on 3 October For information on changes after this date please refer to the module Update.

2 I. INTRODUCTION Based on the review of the quality, safety and efficacy data, the Medicines Evaluation Board (MEB) of the Netherlands has granted a marketing authorisation for Calcium and Vitamine D3 Alpex 1000 mg/880 IE, effervescent granules from Alpex Pharma (UK) Limited. The product is indicated for: Correction of combined calcium and vitamin D deficiency in elderly patients Calcium and vitamin D supplementation as an adjunct to specific therapy for osteoporosis, in patients with an established increased risk of combined calcium and vitamin D deficiency. A comprehensive description of the indications and posology is given in the SmPC. Vitamin D increases the intestinal absorption of calcium. Vitamin D supplementation corrects an insufficient vitamin D intake. Oral intake of calcium supplementation corrects a deficiency of calcium in the diet and supports the remineralisation of the skeleton if there is a lack of calcium in the diet. Oral intake of vitamin D3 corrects a vitamin D deficiency when both intake of vitamin D and sunlight exposure are inadequate. Vitamin D increases the intestinal absorption of calcium. Combined calcium and vitamin D3 administration corrects secondary senile hyperparathyroidism by counteracting the increase in parathyroid hormone (PTH) which is caused by calcium and vitamin D3 deficiency and which causes increased bone resorption. This national procedure concerns a generic application claiming essential similarity with the innovator product CaD 1000/880 citroen, effervescent granules (NL License RVG 18867), which has been registered by Will Pharma B.V. since 10 June The marketing authorisation has been granted pursuant to Article 10(1) of Directive 2001/83/EC. II. QUALITY ASPECTS II.1 Introduction Calcium and Vitamine D3 Alpex 1000 mg/880 IE contains per sachet 2500 mg calcium carbonate, corresponding to 1000 mg calcium, and cholecalciferol concentrate powder corresponding to 880 IE (equivalent to 22 µg of vitamin D3). The product is an effervescent granulate with white to off-white effervescent granules, divided in sachets. Excipients are citric acid, maltodextrin, lemon-lime flavour, sucralose, modified starch, silica colloidal anhydrous (Aerosil 200), sucrose, sodium ascorbate, medium chain triglycerides, silicon dioxide and alpha-tocopherol. The effervescent granulate is packed in in Paper/PE/Al/PE sachets. II.2 Drug Substances The active substances are calcium carbonate and cholecalciferol (vitamin D 3 ), established active substances, described in the European Pharmacopoeia (Ph.Eur.). Calcium carbonate is a well known established inorganic salt in the form of a white or almost white powder, which is practically insoluble in water. Cholecalciferol is a well known established vitamin (D 3 ) in the form of white or almost white crystals that are practically insoluble in water, but freely soluble in ethanol 96%. A powder concentrate is manufactured. 2/6

3 The CEP procedure is used for the active substances. Under the official Certification Procedures of the EDQM of the Council of Europe, manufacturers or suppliers of substances for pharmaceutical use can apply for a certificate of suitability concerning the control of the chemical purity and microbiological quality of their substance according to the corresponding specific monograph, or the evaluation of reduction of Transmissible Spongiform Encephalopathy (TSE) risk, according to the general monograph, or both. This procedure is meant to ensure that the quality of substances is guaranteed and that these substances comply with the European Pharmacopoeia. Manufacturing process A CEP has been submitted for both active substances; therefore no details on the manufacturing process have been included. Quality control of drug substance The drug substance specifications for calcium carbonate and cholecalciferol have been provided and are in compliance with the Ph.Eur. Batch analytical data demonstrating compliance with the drug substance specification have been provided for two batches of calcium carbonate, and three full-scale batches of cholecalciferol concentrate. Stability of drug substance For calcium carbonate a retest period of 1 year is claimed and supporting stability data have been provided. Stability data on the active substance cholecaliferol concentrate have been provided for three fullscale batches stored at 25 C/60% RH (48 months) and 40 C/75% RH (6 months). No trends or out of specification results were observed during the stability studies. The retest period of 60 months with the storage condition Store in the unopened original container and at a temperature of 5 C ± 3 C is acceptable. II.3 Medicinal Product Pharmaceutical development The development of the product has been described, the choice of excipients is justified and their functions explained. Since the test product is an aqueous oral solution at the time of administration and it contains active substances in the same concentrations as approved oral solutions, the bioequivalence study may waived according to the Guideline on the investigation of bioequivalence. Thus, from a chemical pharmaceutical point of view the test and reference product are bio-equivalent and no further bioequivalence studies are required. A formulation study has been performed in order to formulate an effervescent product with the following general characteristics: - aspect of the granular: white without foreign bodies; - weight of the sachets - effervescent granular which completely dissolves in about 200 ml tap water - ph of the drinking solution between 4 and 5. The MAH adequately demonstrated that the test and reference product both dissolved within 5 minutes. Overall, the pharmaceutical development has been adequately performed. Manufacturing process A non standard manufacturing process has been employed based on the amount of cholecalciferol in the final drug product. The whole process may be subdivided in three main steps: granulation, blending and packaging. The manufacturing process has been validated on three full-scale batches demonstrating that the process is adequate to manufacture the product consistently. Control of excipients Almost all of the excipients comply with the Ph.Eur. These specifications are acceptable. The lemonlime flavour has in house specifications. The specification is acceptable. A specification for the cholecalciferol concentrate has been provided and is in line with the Ph.Eur. monograph. Quality control of drug product 3/6

4 The product specification includes tests for appearance of granules, solution and sachets, ph of the solution, average weight, loss on drying, identification of calcium and cholecalciferol, assay of calcium and cholecalciferol, seal test, uniformity of dosage units and microbiological characteristics. Furthermore a forced degradation study demonstrated the stability indicating capabilities of the assay methods. There is no difference between the release and shelf-life specification. The analytical methods included in the specification have been adequately described and validated. Batch analytical data from the proposed production site have been provided on three batches, demonstrating compliance with the specification. Stability of drug product Stability data on the product has been provided on three full-scale batches stored at 25 C/60% RH (12 months) and 40 C/75% RH (6 months). The conditions used in the stability studies are according to the ICH stability guideline. The batches were stored in paper/pe/al/pe sachets. Exposure to UV light did not show degradation. Based on the submitted data the proposed shelf life of 24 months stored in a Paper/PE/Al/PE sachet with the storage condition store below 25 C is acceptable. Post approval the shelf life was extended to 36 months. Specific measures concerning the prevention of the transmission of animal spongiform encephalopathies On the CEP of cholecalciferol it is mentioned that sheep wool is used in the manufacturing of the drug substance. However, it meets the criteria described in Ph.Eur. monograph Products with risk of transmitting agents of animal spongiform encephalopathies as mentioned on the CEP. II.4 Discussion on chemical, pharmaceutical and biological aspects Based on the submitted dossier, the MEB considers that Calcium and Vitamine D3 Alpex 1000 mg/880 IE, effervescent granules has a proven chemical-pharmaceutical quality. Sufficient controls have been laid down for the active substance and finished product. III. III.1 NON-CLINICAL ASPECTS Ecotoxicity/environmental risk assessment (ERA) Since Calcium and Vitamine D3 Alpex 1000 mg/880 IE is intended for generic substitution, this will not lead to an increased exposure to the environment. An environmental risk assessment is therefore not deemed necessary. III.2 Discussion on the non-clinical aspects This product is a generic formulation of CaD 1000/880 citroen, effervescent granules which is available on the European market. Reference is made to the preclinical data obtained with the innovator product. A non-clinical overview on the pharmacology, pharmacokinetics and toxicology has been provided, which is based on up-to-date and adequate scientific literature. The overview justifies why there is no need to generate additional non-clinical pharmacology, pharmacokinetics and toxicology data. Therefore, the MEB agreed that no further non-clinical studies are required. IV. IV.1 CLINICAL ASPECTS Introduction Calcium carbonate and cholecalciferol are a well-known active substance with established efficacy and tolerability. 4/6

5 A clinical overview has been provided, which is based on scientific literature. The overview justifies why there is no need to generate additional clinical data. Therefore, the MEB agrees that no further clinical studies are required. IV.2 Pharmacokinetics Biowaiver Since the test product is an aqueous oral solution at the time of administration and it contains active substances in the same concentrations as the reference product, the bioequivalence study is waived according to the Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98/Rev1). Calcium and Vitamine D3 Alpex 1000 mg/880 IE may be considered as therapeutic equivalent, with the same efficacy/safety profile as known for the active substance of the reference medicinal product. The current product can be used instead of its reference product. IV.3 Risk Management Plan The MAH did not submit a risk management plan, as it was not required at the time the application was made. This is acceptable. Both active substances are well known. The MAH has a pharmacovigilance system in place, in compliance with the applicable guidelines. IV.4 Discussion on the clinical aspects For this authorisation, reference is made to the clinical studies and experience with the innovator product CaD 1000/880 citroen, effervescent granules. No new clinical studies were conducted. The product is essentially similar to the reference product. Risk management is adequately addressed. This generic medicinal product can be used instead of the reference product. V. USER CONSULTATION The package leaflet (PL) has not been evaluated via a user consultation study. The text of the PL is the same as already approved and in force for the reference medicinal product CaD 1000/880 citroen, effervescent granules. The lay-out and style of the proposed PL is also very similar to the innovator s. The MEB agrees that additional user testing is not necessary. VI. OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND RECOMMENDATION Calcium and Vitamine D3 Alpex 1000 mg/880 IE, effervescent granules has a proven chemicalpharmaceutical quality and is a generic form of CaD 1000/880 citroen, effervescent granules. CaD 1000/880 citroen is a well-known medicinal product with an established favourable efficacy and safety profile Since both the reference and current product are administered as an aqueous solution, at the same concentration of active substances, no bioequivalence study is deemed necessary. The Board followed the advice of the assessors. The MEB, on the basis of the data submitted, considered that essential similarity has been demonstrated for Calcium and Vitamine D3 Alpex with the reference product, and have therefore granted a marketing authorisation. Calcium and Vitamine D3 Alpex 1000 mg/880 IE, effervescent granules was authorised in the Netherlands on 3 October /6

6 STEPS TAKEN AFTER THE FINALISATION OF THE INITIAL PROCEDURE - SUMMARY Scope Extension of the shelf-life of finished product from 24 to 36 months. Change in the batch size of the finished product up to 10-fold compared to the originally approved batch size. Type of modification Date of start of the procedure Date of end of the procedure Approval/ non approval Assessment report attached IB Approval No IA Approval No 6/6

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